Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: metreleptin
Trade Name: MYALEPT
Date Designated: 08/22/2001
Orphan Designation: Treatment of metabolic disorders secondary to lipodystrophy
Orphan Designation Status: Designated/Approved
Chiesi Farmaceutici S.p.A.
Via Palermo 26/A
Parma, Emilia Romagna 43122
Italy

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: metreleptin
Trade Name: MYALEPT
Marketing Approval Date: 02/24/2014
Approved Labeled Indication: Adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
Exclusivity End Date: 02/24/2021 
Exclusivity Protected Indication* :  Adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-